Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability (BoneGlyc)

Centro de Diabetes Curitiba Ltda

Status and phase

Completed

Phase 4

Conditions

Osteopenia

Osteoporosis

Menopause

Type 2 Diabetes Mellitus

Treatments

Drug: Vildagliptin

Drug: Gliclazide MR

Study type

Interventional

Funder types

Other

Identifiers

NCT01679899

BoneGlyc

Details and patient eligibility

About

This is a Monocentric, Prospective, Randomized, Open-label, Comparative, Phase IV Study, to compare the effects of Vildagliptin and Gliclazide MR on Markers of Bone Remodeling, Bone Mineral Density and Glycemic Variability in Postmenopausal Women with Type 2 Diabetes.

A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. The active treatment will include a 50 mg dose of vildagliptin OD twice a day. As comparator, gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.

Full description

Target population of clinical trial subjects A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. To be as close to a real life scenario as possible, clinical trial subjects which are treated with glucose-lowering medication (except incretin or sulfonylurea based therapies) and treatment-naive subjects will be included.

Investigational Product, posology and method of administration The active treatment will include a 50 mg dose of vildagliptin OD twice a day.

Comparator, posology and method of administration As comparator, gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.

Treatment duration The study will have an expected total duration of 18 months, 12 months of active treatment.

Enrollment

56 patients

Sex

Female

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent form obtained before any study-related activity. Study-related activities are any procedure that would not be performed during the normal treatment of the patient.
All study subjects must be women diagnosed with type 2 diabetes based on current guidelines of Sociedade Brasileira de Diabetes (SBD - Brazilian Society of Diabetes) and/or American Society of Diabetes (ADA) and they should have all the following criteria:
- Age ≥ 40 years old.
- HbA1c ≥ 6.5% at randomization.
Menopause defined as:
Absence of menstruation for at least 12 months in patients with an intact uterus, or
FSH level greater than 30 mIU/mL in a hysterectomized patient and/or,
FSH level greater than 30 mIU/mL in a patient with surgical menopause.

Exclusion criteria

Acute vascular event (cardiac, cerebral or peripheral) for at least 2 months of randomization.
Patient on chronic dialysis and/or renal transplantation and/or serum creatinine > 1.5 mg/dL.
Patients with HIV, severe autoimmune disease or chronic treatment with oral steroids (> 30 consecutive days).
Current or previous treatment (within 6 months) with incretin (DPP-IV inhibitor or GLP-1 analog) within 6 months prior to randomization.
Current or previous treatment with pioglitazone or rosiglitazone within 12 months prior to randomization.
Sustained arterial hypertension > 180/100 mm Hg.
Body mass index (BMI) > 50 kg/m².
HbA1c ≥ 9,5% at randomization.
Transaminases (AST (SGOT) and ALT (SGPT)) > 2.5 x upper limit of normal.
Chronic liver disease or alcoholic liver disease.
LDL-cholesterol > 250 mg/dL (> 6.48 mmol/L).
Triglycerides > 1000 mg/dL (> 11.3 mmol/L).
HDL-cholesterol < 25 mg/dL (< 0.64 mmol/L).
Levels of 25-OH-vitamin D < 20ng/mL at randomization
Abnormal levels of PTH, cortisol, IGF-1 or GH at randomization
Prescription of any investigational medication within one year before the screening visit (visit 1), unless there is a direct benefit to the study subject, at the discretion of the investigator.
History of previous fracture
Pregnant or breastfeeding patients.
Previous participation on this study.
Individuals at risk for poor adherence to the protocol or medication.
Any condition that makes the patient unable to complete the study within 12 months.